The Impact of the Top 3 Strategic Imperatives on Digital Health Regulation Industry

Disruptive Technologies

Why:

• The rapid evolution of disruptive technologies outpaces the development of regulatory frameworks.
• Its impact encompasses issues related to data privacy, ethics, regulatory guidance, clinical decision support, liability, and patient safety.

Frost Perspective:

• While guidance is still in the early stages of development, regulatory concerns are expected to increase regarding technologies such as generative artificial intelligence (AI) and large learning models (LLMs) in the clinical field during the next five years.
• Regulatory bodies will turn to digital health technology market leaders and its users, such as physicians' associations, for feedback on efficient measures.

Internal Challenges

Why:

• Challenges, such as a lack of guidance in ethics and governance in the private sector, can pose obstacles to the development and regulation of digital health technologies.
• Regulatory bodies play a crucial role in addressing these challenges to ensure that ethical standards, accountability, and best practices are upheld in the healthcare industry.

Frost Perspective:

• Physicians will continue to have concerns about potential ways in which digital health technologies can affect their daily clinical workflow, affecting application rates. A clear understanding of the role of each party (physician, payer, and technology provider) and further interoperability will be demanded.
• Lobbying to guard digital health providers' business interests will increase in the next five years.

Innovative Business Models

Why:

• Value-based care (VBC) is driving changes in how healthcare is delivered and reimbursed.
• Digital health regulation must adapt to these new models, addressing challenges related to data sharing, payment structures, technology adoption, and patient engagement to ensure its successful implementation and scalability.

Frost Perspective:

• As each region and country sets its own agenda to support the business model transformation towards VBC, regulatory bodies will take measures to ensure that they achieve their goals within the desired timelines.
• Regulatory bodies will adapt requirements on-the-go according to the impact analyzed, users’ feedback, and case laws.

Key Questions Addressed by this Study:

• What are the growth opportunities to consider across the United States, Canada, EU member states, and the United Kingdom when developing a digital health governance framework?
• What are the key digital health regulations introduced by the United States, Canada, EU, and United Kingdom in 2023?
• Which digital health markets have digital health regulations in the regions mentioned above had an impact on?
• What digital health markets receive incentives from government regulations and funding?
• What will be the regulatory trends for 2024 in digital health?

Project Scope

Market Segmentation

Digital Health Regulation

United States

Regulatory bodies analyzed include:

• US Congress
• Department of Health and Human Services (HHS)
• Food and Drug Administration (FDA)
• Centers for Medicare & Medicaid Services (CMS)

Canada

Regulatory bodies analyzed include:

• Parliament of Canada
• Health Canada
• Public Health Agency of Canada
• Canadian Institutes of Health Research
• Canadian Agency for Drugs and Technologies in Health (CADTH)
• Infoway (Canada Health Infoway)

EU Member States

Regulatory bodies analyzed include:

• European Parliament
• European Medicines Agency (EMA)
• EU4Health Program (2021-2027)
• European Health Union
• European Health and Digital Executive Agency (HaDEA)
• European Health Data Space

United Kingdom

Regulatory bodies analyzed include:

• UK Parliament
• National Health Service (NHS)
• National Institute for Health and Care Excellence (NICE)
• Care Quality Commission (CQC)